8
Roadmap and Recommendations: Creating an Optimized System for TBI
The physical, psychological, and social effects of traumatic brain injury (TBI) along the full range of severity and with time horizons longer than the acute phase of management can have significant impacts on a person’s function, relationships, and quality of life. The evidence and testimony reviewed by the committee suggest that many persons with TBI and their families find themselves without continuity of care or the full support needed downstream from an acute brain injury. In addition, as in almost all aspects of U.S. health care, TBI care and outcomes show evidence of racial, geographic, and socioeconomic inequities. Achieving high-quality care for all persons with TBI will depend on careful redesign of TBI care and research as an integrated system and as a “learning system” capable of continual progress toward ideal TBI care everywhere and for everyone.
These findings led the committee to draw four overarching conclusions that informed its recommendations for creating an optimized system for TBI care:
Conclusion: TBI care in the United States often fails to meet the needs of individuals, families, and communities affected by this condition. TBI is an ongoing condition that poses significant burdens over time, including substantial financial and social costs. For the most part, the nation has no mechanism in place for long-term follow-up and care of adults or children with TBI. The results of this gap include needless death, squandered human potential, family stress, and soaring social costs. Because of this gap, the true morbidity, mortality, and cost attributable to TBI, though undoubtedly vast, are unknown.
Conclusion: High-quality care for TBI requires that it be managed as a condition with both acute and long-term phases. Helping people with TBI and their families effectively requires that clinicians and community services address and improve the factors that affect care and recovery. After acute treatment, many people living with TBI drop into a black hole, lost to follow-up and without clear pathways to providers. Millions of people, especially in marginalized groups, face inequitable challenges
that could have been avoided. In this black hole, there are no mechanisms for collecting data with which to document and improve these shortfalls in TBI care.
Conclusion: Public and professional misunderstandings are widespread with respect to the frequency; manifestations; long-term consequences; and proper detection, treatment, and rehabilitation of TBI.
Conclusion: The United States lacks a comprehensive framework for addressing TBI. A barrier to dramatic improvement in TBI care and research is the absence of a strategic framework and a lead agency or organization with a systemic view, responsibility for articulating goals and overseeing progress, the capacity to foster change, and the ability to convene the many stakeholders required to address the necessary multiple lines of effort. Absent a leadership entity, no one owns the problem, and major progress is unlikely.
AN OPTIMIZED SYSTEM FOR TBI
An optimized system for TBI needs to embody a number of key features, including integration across the phases of care and recovery and between the health care system and the research enterprise. Moreover, comprehensive and personalized care for TBI requires considering bio-psycho-socio-ecological (BPSE) dimensions beyond the injury itself. BPSE factors influence the recognition, initial management, and even immediate survival from TBI, as well as recovery; rehabilitation; and reintegration into employment, family, and social life. Research over the past decade has demonstrated that BPSE factors should help inform all phases of care. However, TBI care and management currently focus on acute presentation and the biological nature of the injury, and these factors are not adequately addressed by the current system. BPSE factors are also elements of disparities in risks, access to care, and outcomes after TBI that are associated with racial, ethnic, socioeconomic, geographic, and other subsets of the population. Continued failure to address the roles of these factors in care and outcomes is no longer tenable. The importance of BPSE dimensions also requires that a team-based approach be taken to managing TBI care and undertaking research aimed at achieving optimal clinical outcomes. Given the scope, scale, and heterogeneity of TBI, the optimized TBI system envisioned by the committee needs to incorporate a broad range of stakeholders and partners. Essential features of a truly optimized system for TBI include those described below.
Incorporates prevention, along with care and research. An optimized system for TBI starts with prevention. Efforts to prevent the occurrence or mitigate the severity of brain injuries make care necessary for as few individuals as possible.
Is person- and family-centered.1 An optimized system takes a holistic approach to patient needs. At the core of the system is an understanding of and appreciation for the needs and perspectives of the people, families, and communities affected by TBI. Such a system engages persons with TBI and their families in both research and clinical care and considers the needs of all patients, with particular attention to those most vulnerable to poor outcomes.
___________________
1 Person-centered care is “the experience (to the extent the informed, individual patient desires it) of transparency, individualization, recognition, respect, dignity and choice in all matters, without exception, related to one’s person, circumstances, and relationships in health care” (Berwick, 2009, p. w560).
Uses a precise classification system. An optimized system relies on an accurate framework to characterize and classify TBI, contributing to more accurate and precise diagnosis, prognostication, monitoring, and research.
Provides the best possible care for everyone. An optimized system uses results of research conducted in real-world care settings to inform clinical practice, while at the same time, results and needs gleaned from clinical practice inform research efforts. The knowledge and understanding thus acquired make it possible to develop and disseminate evidence-based guidelines on best practices for care while supporting care that is personalized to both individuals and families. A system that provides the best possible care also strives to identify and address sources of disparities in access to high-quality TBI care and outcomes, including racial and ethnic, geographic, socioeconomic, and other sources of inequities.
Provides seamless transitions across the continuum of care. An optimized system supports connections among all components of the TBI landscape, building awareness of the interdependencies and promoting communication and collaboration.
Builds accountability and quality improvement into the system. An optimized system incorporates the capacity to identify and implement metrics of quality and to harness the resulting information to better meet patient and family needs.
Is transformed into an integrated learning system. Establishing a system is necessary but not sufficient; an optimized system for TBI is a learning system. The attributes of a learning health system have been defined in prior reports from the National Academies (IOM, 2007; NASEM, 2016). Such a system “is predicated on the active collaboration of all members of the system, from patients to clinicians to health system leaders, and success is defined by the impact of the system on the health and lives of patients.”2 A learning system for TBI enhances the ability to identify which gaps and challenges impede improved care and to work collectively across the system to address them. Table 8-1 summarizes essential components of a learning system and their application to TBI.
Incorporates leadership invested in making change happen. An optimized, learning system for TBI includes leaders and champions who embrace the system’s mission and vision. These leaders support, implement, and sustain effective change.
RECOMMENDATIONS
Achieving the optimized TBI system described above will require addressing the current gaps and challenges in TBI care and research detailed in this report. For many people with TBI and their families, a “continuum of care” does not exist. Their journey is more aptly characterized as a fragmented series of silos (prehospital assessment, potential emergency department or hospital-based acute care, perhaps inpatient or outpatient rehabilitation, and possibly additional community or long-term services and supports) that is also insufficiently connected to fundamental and translational research. To effect the changes required to realize an optimized TBI system, it will be necessary to leverage the collaborative opportunities laid
___________________
2 Remarks by Mate, K. 2021. “Introduction to a Learning Health System.” Presentation and discussion during virtual workshop for the Committee on Accelerating Progress in Traumatic Brain Injury Research and Care, March 30, 2021.
TABLE 8-1 Components of a Learning Health System and Their Implications for an Optimized TBI System
| Characteristic* | Implications for TBI |
|---|---|
| Science and Informatics | A Learning System for TBI… |
| Real-time access to knowledge |
|
| Digital capture of the care experience |
|
| Patient–Clinician Partnerships | |
| Engaged, empowered patients |
|
| Incentives | |
| Incentives aligned for value |
|
| Full transparency |
|
| Continuous Learning Culture | |
| Leadership-instilled culture of learning |
|
| Supportive system competencies |
|
* From NASEM, 2016.
out in Chapter 7 through evidence-based actions by all stakeholders and through research efforts aimed at addressing issues for which the evidence base is currently insufficient. The following sections present the committee’s recommendations for actions to advance the TBI field toward an optimized system and for a research agenda to produce the evidence needed to support additional actions. Collectively, these recommendations and this research agenda constitute the committee’s roadmap for advancing TBI care and research.
TBI Classification
The currently used classification of TBI as “mild, moderate, or severe” and reliance on the Glasgow Coma Scale to determine which of these categories applies to an individual patient are insufficiently nuanced and discriminating to support TBI treatment and prognosis utilizing the best available knowledge. Initial assessment of a TBI often does not predict the evolution of a person’s condition over time or ultimate outcome. The care system therefore needs to support more precise diagnosis, prognostication, monitoring, and research. A TBI classification workshop was held by the National Institutes of Health’s National Institute of Neurological Disorders and Stroke (NINDS) in 2007. The years since then have seen progress in imaging, blood-based, and other biologic markers and their relationship to understanding TBI pathophysiology and outcome that can be reviewed for incorporation in an improved classification scheme. Such discussions will need to consider the utility of the various markers across different TBI populations and injury severities and in different care environments.
Recommendation 1. Create and implement an updated classification system for TBI. The current clinical classification scheme for TBI should be updated to be more accurate and informative for care and research:
- The National Institutes of Health (NIH) should convene a TBI Classification Workgroup to review data from recent large-scale clinical studies and determine which elements should be incorporated into a more descriptive, evidence-based, and precise classification system for clinical care and research. In this effort, NIH should engage professional communities that routinely diagnose and classify TBI.
- Relevant professional societies, including but not limited to those in emergency medicine, trauma care, and rehabilitation, should advise and train clinicians caring for people with TBI to classify patients based on their actual Glasgow Coma Scale (GCS) sum score (e.g., GCS 14) rather than the inaccurate and misleading three-category shorthand mild, moderate, or severe. Optimally, clinicians should also use results from neuroimaging and blood-based biomarkers, when available and clinically indicated, to classify patients. Clinicians should update the TBI classification for each patient as the person’s condition evolves.
TBI as a Complex Acute and Chronic Condition
It is essential to recognize that TBI often has both acute and long-term physical, social, and psychological consequences, and that a person with TBI may experience ongoing, new, or worsening symptoms after discharge. Thus, individuals experiencing TBI frequently need long-term, person-centered support that may require months, years, or even a lifetime of care and adjustment. Accordingly, continuity of TBI care is crucial to quality. Also crucial is for TBI care to take into account the social determinants of health.
Recommendation 2. Integrate acute and long-term person- and family-centered management of TBI. All people with TBI should have reliable and timely access to integrated, multidisciplinary, and specialized care to address physical, cognitive, and behavioral sequelae of TBI and comorbidities that influence quality of life.
- Relevant professional societies should encourage clinicians to recommend that all patients at discharge from inpatient and outpatient acute care settings have an opportunity for follow-up with a clinician experienced in managing TBI. Guidance to clinicians should also emphasize the need to connect patients and family caregivers with care navigation resources as needed.
- In their intake processes, health care and social services organizations should be aware of lifetime TBI exposure so they can identify those needing accommodations, as well as those at increased risk for TBI-related symptoms or declining trajectories in health and function. These organizations should also give providers guidance on practical strategies and accommodations that can help patients and families cope with TBI-related symptoms, and on resources that can increase reliable and timely access to and appropriateness of care for persons with TBI.
- Organizations that oversee or provide long-term care should consider the needs of families and caregivers for education and support as key components of long-term care plans.
Ensuring quality and continuity of care for all people with TBI is essential. Making progress toward a system that rewards a linked and coordinated continuum of care and supports optimal longer-term outcomes can also help address some of the inequities that exist around access to post-acute and rehabilitation care. Incorporating family and caregiver needs is critical as well, since many persons with TBI live with family and are dependent on family members and other caregivers to address their needs, navigate health care and community services, and facilitate community integration.
Quality of Care
TBI care in the United States too often deviates from known best practices in both the acute and chronic phases of care. Stronger commitment to and strategies for ensuring quality and continuity of care for all TBI patients, regardless of sex, age, race/ethnicity, socioeconomic status, geographic location, and other individual characteristics, are essential so that who you are and where you live do not determine whether and how you live. To this end, it will be necessary to address variability and gaps in available care guidance and in the implementation of existing guidelines, including their use to guide reimbursement practices (see also Recommendation 6). The evidence base informing acute and longer-term TBI care and rehabilitation needs to be expanded. In so doing, the evidence to inform TBI care decisions will need to be based on a range of rigorous methodologies for generating knowledge and include evidence obtained not only from randomized controlled trials but also from observational cohort and other study designs and from expert consensus on best practices.
Recommendation 3. Reduce unwarranted variability and gaps in administrative and clinical care guidance to ensure high-quality care for TBI. The federal agencies that lead the development of clinical practice guidelines for TBI, including the Department of Veterans Affairs, the Department of Defense, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention, should convene at
regular intervals an expert panel to undertake the actions below in collaboration with clinical and patient community stakeholders. The Centers for Medicare & Medicaid Services (CMS) should be engaged in this effort to ensure alignment of coverage with clinical guidelines:
- Survey the landscape of existing clinical care guidelines for all elements of TBI care, during all phases of care, and involving all salient specialties. Synthesize best current clinical practice and evidence to develop consensus-based guidelines where evidence is currently limited, using rigorous methods for such consensus processes. Guidelines should be sensitive to local contexts and potential sources of inequity, such as race/ethnicity, rurality, and limited access to health care resources.
- Identify and resolve problems of inconsistency among current clinical care guidelines.
- Identify guidelines and practices that are contraindicated by current evidence, and issue guidance on their deimplementation.
- Identify common criteria for the inclusion of studies used to inform the development of guidelines and for how topics are covered for which limited evidence from randomized controlled trials or other rigorous study designs is available (see Recommendation 7).
- Identify gaps in the evidence base informing current clinical care guidelines, and recommend research to develop the necessary evidence (see also gaps identified in the research agenda presented later).
- Develop evidence-guided and consensus-based criteria for identifying patients who should be referred to inpatient and outpatient TBI rehabilitation (see Recommendation 5).
- Identify avenues for emerging best practices to guide third-party coverage of care, regardless of payer source and type of medical facility.
Relevant clinical organizations that have been active in TBI guideline development and can be engaged in this effort include the Brain Trauma Foundation, Concussion in Sport Group, American College of Surgeons, American Academy of Neurology, American College of Emergency Physicians, American Congress of Rehabilitation Medicine, Neurocritical Care Society, and others.
Awareness and Understanding
Too large a fraction of TBI is unrecognized as such, either at the time of injury or as symptoms and signs develop after injury. Both the public at large and clinicians need better understanding of the condition and information on types of supports or accommodations persons with TBI may need in their daily lives.
Recommendation 4. Enhance awareness and identification of TBI by health care providers and the public. Education and awareness are essential for achieving high-quality care and improving outcomes, and are particularly important in the following areas:
- Public awareness. The Centers for Disease Control and Prevention, working with organizations in TBI prevention, care, and rehabilitation and those that work with at-risk groups, should enhance efforts to raise awareness among the public on the context, causes, and long-term effects of TBI; the importance of follow-up; and resources that may be available to the person with TBI.
- Professional awareness, education, and training. Education and training programs for health care professions should include information on the burden, risk factors, and signs and symptoms of TBI and should correct misconceptions about the condition. Materials should emphasize adherence to evidence-based guidelines where they exist to bring greater consistency to TBI care across the United States, while taking into account patient characteristics and preferences in order to provide personalized care. Guidance should also emphasize eliminating practices that are contraindicated by current evidence and reducing inequities in care and outcomes.
- Patient and family empowerment. National- and state-level patient and family organizations should work with clinical communities in primary care, acute care, and rehabilitation to ensure that all TBI patients and families receive anticipatory guidance on expected symptoms and trajectory, steps to decrease the risk of delayed recovery, and available TBI resources.
Multiple professionals across the health care enterprise, including emergency medical technicians, physicians, nurses, psychologists, and rehabilitation professionals, need sufficient training and guidance on TBI; however, few clinical training curricula address TBI risk factors, diagnosis, and management in any depth. Organizations working closely with communities at particular risk of experiencing a TBI or at risk of poorer outcomes after TBI should be part of efforts to develop and disseminate practical information. Given the complexities of the care systems for conditions such as TBI, engaging investigators with complementary expertise in such areas as social sciences, implementation science, and cost analysis and health economics is also an important part of the roadmap for advancing TBI care and research.
The Care System
Challenges and unmet needs in TBI care and recovery illustrate systemic issues in U.S. health care. As is the case with many chronic illnesses in the United States, care for TBI can be fragmented; interrupted; and unresponsive to the evolving medical, psychological, and social support needs of TBI patients and their families. At present, no entity is “in charge” of ensuring continuity of care or follow-up for TBI patients, and as a result, many patients feel lost and even abandoned as their condition evolves. Inequities in TBI outcomes also become magnified when only some patients and families have access to high-quality care across the full continuum or have insurance coverage or financial resources to pay for such care, particularly for rehabilitation and longer-term services. To address this gap, professional societies should confront and mitigate the problems of care discontinuity; government and private philanthropy should invest in developing prototypes of integrated TBI care, including regional system designs; and public and private payers should ensure that benefit structures accord with the evidence for proper TBI care across all phases and environments of care.
Recommendation 5. Establish and reinforce local and regional integrated care delivery systems for TBI. The Secretary of Health and Human Services should work to establish geographically based, integrated care delivery systems for TBI, emphasizing the continuum of care across the acute, rehabilitation, and recovery phases and all severities. The effort should build on the nation’s success with regional trauma systems and incorporate practices and lessons learned from the Department of Defense (DoD) and the Department of Veterans Affairs (VA). Specifically:
- The American College of Surgeons (ACS) and other trauma verification systems should incorporate comprehensive standards for TBI care in trauma center verification processes and data systems and as a national trauma system evolves. As part of this effort, ACS should expand efforts to foster communication between acute care and rehabilitation care providers and expand outreach on the signs and management of TBI to the public, first responders, and acute care providers.
- Settings that provide TBI care across the post-acute rehabilitation continuum should meet standards for integrated, evidence-based, and individualized brain injury care, such as those required by the Commission on Accreditation of Rehabilitation Facilities for the Brain Injury Specialty. The Joint Commission should review and promulgate standards for high-quality TBI care in the broader spectrum of care settings that treat people with TBI, such as primary care, community hospitals, and concussion programs.
- The Department of Health and Human Services and the Center for Medicare and Medicaid Innovation should support local and regional pilot demonstration projects to create prototype civilian care infrastructures focused on providing continuity of care for follow-up, rehabilitation, and longer-term care and recovery from TBI. The demonstration projects should document best practices and effects on patient outcomes, and identify the components of a chronic care management model that are most effective for persons with TBI. Prototype systems should address the needs of TBI across the spectrum of severity and venues of care, including community-based services.
- The Centers for Medicare & Medicaid Services (CMS) and commercial health care insurers should align coverage for TBI care with clinical guidelines to ensure equity in access to, affordability of, and quality of care. For example, payers should use criteria identified under Recommendation 3 when authorizing inpatient and outpatient rehabilitation services, including for long-term TBI sequelae. CMS, the VA, and DoD should test alternative benefit structures for TBI rehabilitation care instead of relying on the current time-based metric (e.g., the “3-hour rule”) or preset benefits.
These types of activities support the delivery of high-quality care, and the actions identified in this recommendation are aimed at multiple parts of the TBI care system. Although not every trauma center participates, ACS and other organizations operate programs that verify the presence of components identified as being part of optimal trauma care. ACS also operates a consultation process for trauma systems interested in obtaining guidance.3 The CARF Brain Injury Specialty Program designation or demonstration of equivalent standards operates for provision of integrated and specialized rehabilitation care, while the Joint Commission is the largest accreditor of health care organizations in the United States.
A Learning System
As discussed above, multiple reports from the National Academies have described the ideal properties of a learning health care system, and TBI care should have those properties. In addition to care and research, such a learning system encompasses processes for quality improvement and education. A full learning system for TBI also involves public health agencies and community organizations across the phases of prevention, care, and recovery.
___________________
3 See https://www.facs.org/quality-programs/trauma/tqp/systems-programs/tscp.
To support a learning health care system, high-quality, comprehensive data spanning prehospital, acute, rehabilitation, and longer-term care for TBI need to be available. Although a number of relevant databases and components of such a data enterprise exist, they currently do not form a connected system, making it difficult to define the full scope and burden of TBI and improve its management. Relevant databases are owned by multiple federal agencies and organizations, which will need to work together to address this challenge. For example, the Department of Transportation’s National Highway Traffic Safety Administration manages the National Emergency Medical Services Information System (NEMSIS). ACS maintains a National Trauma Databank and Trauma Quality Improvement Program, and individual state trauma registries exist as well. The National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) TBI Model Systems network, operated under the Department of Health and Human Services’ Administration for Community Living, maintains longitudinal data, which are especially relevant to rehabilitation care. DoD has a Trauma Registry, and the VA similarly operates registries containing information on TBI. Better linking these data sources across sites and through time can provide one of the foundations for a learning system capable of continual analysis and improvement.
Recommendation 6. Integrate the TBI system of care and TBI research into a learning health care system. Reducing the burden of TBI will require a learning system capable of continual improvement. Important elements are thorough surveillance, standardized and longitudinal patient information, and accessibility of data. The Secretary of Health and Human Services (HHS) should therefore work to establish an integrated TBI data system, taking the following actions:
- Conduct thorough surveillance. The Centers for Disease Control and Prevention should expand efforts to track TBI mortality, morbidity, and long-term outcomes more completely and accurately, including by adding validated, standardized TBI questions to population-based and weighted surveys and working to ensure consistency of information across states and surveys. The Agency for Healthcare Research and Quality should modify and expand the Healthcare Cost and Utilization Project to enable improved analysis of TBI care patterns, costs, and outcomes, both acute and long-term.
- Standardize the capture of patient-level data. HHS should work with health care systems and electronic health record vendors to bring data infrastructure into line with the state of the science by investing in and developing the ability to capture high-quality, TBI-relevant data in medical records. This data infrastructure will help in identifying causal factors and longitudinal outcomes, enabling comparative effectiveness, implementation, and translation studies across health care systems.
- Emphasize longitudinal data, and integrate information across the continuum of care. HHS should work with the owners of national and regional TBI registries and databanks to crosslink patient-level data across sites and through time. In addition, data systems should collect clinical information in alignment with the refined TBI classification system proposed in Recommendation 1.
Research
Further research efforts are needed to address gaps and challenges where the evidence base to support action toward more effective TBI prevention, care, and recovery is currently inadequate.
Recommendation 7. Improve the quality and expand the range of TBI studies and study designs. TBI research and investment by the National Institutes of Health, the Department of Defense, the Department of Veterans Affairs, and private-sector funders should be commensurate with the public health burden of the condition. The research agenda proposed herein identifies eight areas for further progress and additional attention. When identifying research priorities and requests for applications, the above funders should take the following actions:
- Significantly expand financial support and research efforts to address the priorities identified in the research agenda.
- Establish translational research and implementation science centers to undertake collaborative efforts toward improved standardization and clinical care for TBI throughout the continuum of care. These centers should use insights from implementation science to enable effective translation of study results from the laboratory to clinical trials and from clinical trials to practice.
- Encourage multidisciplinary and multistakeholder research efforts to strengthen the evidence base informing care. These efforts should:
- Use the TBI classification system called for in Recommendation 1 to better stratify participants in clinical trials of novel interventions for TBI.
- Engage patient and family voices early in study design by using stakeholder engagement (i.e., community-based participatory research) to identify unmet needs and refine research questions.
- Recruit diverse study participants to ensure that research is broadly representative of the people who experience TBI.
- Use all forms of rigorous study designs when appropriate to answer research questions. Study methods should be eclectic and adaptive, and should include not only randomized controlled trials for efficacy but also pragmatic trials, adaptive designs, comparative effectiveness trials, observational studies (including those using statistical control for causal inference), and mixed methods, as appropriate to the research questions.
- Engage laboratory scientists and clinicians to ensure better research translation, including rigorous parallels across animal and human injury models, therapeutic targets, comorbidities, and study design outcome metrics and endpoints.
Leadership
The nation needs but currently lacks leadership to provide a locus for innovation and improvement in TBI care and research, as well as a mechanism for convening stakeholders to better organize TBI care as a system. Federal leadership is needed to establish a strategic framework for dramatically improving TBI care. Because this framework will require the efforts of multiple partners and substantial resources, it will also be essential early on to develop a clear plan for implementation that includes a timeline and metrics of progress and is curated thereafter as circumstances change. This coordinated approach will support innovation and improvement in TBI research and care, and will align the expansive range of partners and stakeholders whose efforts are critical to establishing an optimized system that aims to achieve high-quality care and health equity among all groups and across the lifespan.
Recommendation 8. Create and promulgate a national framework and implementation plan for improving TBI care. The Secretary of Health and Human Services (HHS)
should, under the aegis of the Assistant Secretary for Health, create, promulgate, and curate a strategic national framework and implementation plan for improving TBI care:
- To this end, the Secretary of HHS should establish, for a period of 10 years, a national Traumatic Brain Injury Task Force as a successor to the National Research Action Plan. The TBI Task Force should move beyond an emphasis solely on research coordination to encompass a focus on research implementation and application of the evidence in support of better treatment and systems of care delivery, engaging an expanded group of federal, private-sector, and philanthropic partners. It should enlist and help coordinate TBI-related care improvements among HHS components (such as the Centers for Medicare & Medicaid Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Administration for Community Living, the Agency for Healthcare Research and Quality, and the Health Resources and Services Administration, among others) and should include participation from other relevant departments, such as the Department of Veterans Affairs, the Department of Defense, the Social Security Administration, and the Department of Transportation.
- The TBI Task Force’s first actions should be to develop a strategic framework addressing the issues reflected in the committee’s recommendations and within 2 years, to release a specific implementation plan to guide and coordinate efforts within that framework. This plan should be curated and updated over time.
- The TBI Task Force should engage a multistakeholder public–private coalition to continually advance and accelerate implementation of the national framework and plan. Stakeholders in this coalition should include, but not be limited to, the federal agencies that provide funding for TBI research and clinical care, relevant patient and family advocacy organizations, Veterans service organizations, relevant professional societies, youth and adult sports associations, health payment organizations, philanthropic foundations, and companies developing new tools and treatments for TBI.
A wide range of partners and stakeholders need to be involved in efforts to effect the improvements necessary to transform TBI care and research. DoD and the VA are focused on the delivery of TBI care to military service members and Veterans, as well as on relevant research. Multiple agencies under HHS, including ACL, AHRQ, NIH, CDC, CMS, HRSA, the Food and Drug Administration (FDA), and the Substance Abuse and Mental Health Services Administration (SAMSHA), also play important roles in TBI-related health care delivery, quality, reimbursement, research, regulation, and surveillance. HRSA oversees the Federally Qualified Health Centers, which provide community-based health care services such as those that may be needed by people with TBI. ACL houses NIDILRR’s TBI Models Systems program enabling data collection and research, while AHRQ operates the Healthcare Cost and Utilization Project (HCUP) health care databases, including longitudinal data on hospital-based care.
Numerous professional societies are relevant to TBI care and recovery as well.4 The proposed TBI coalition will also need to include and work closely with patient and family
___________________
4 These societies include, but are not limited to, Academy of Rehabilitation Psychology, American Academy of Clinical Neuropsychology, American Academy of Family Physicians, American Academy of Neurology, American Academy of Nursing, American Academy of Pediatrics, American Academy of Physical Medicine and Rehabilitation, American Association of Critical Care Nurses, American Association of Neurological Surgeons, American College of Emergency Medicine, American College of Sports Medicine, American College of Surgeons, American Congress of Rehabilitation Medicine, American Medical Association, American Medical Rehabilitation Providers Association, American Nurses Association, American Occupational Therapy Association, American Physical Therapy Association, American Psychological Association, American Speech-Language-Hearing Association, American Therapeutic Recreation Association, Association for Behavioral and Cognitive Therapies, Association of Rehabilitation Nurses, National Medical Association, and National Association of State Head Injury Administrators.
advocacy and Veterans’ service organizations. These types of organizations are often financially constrained, further highlighting the fact that to make substantial progress in advancing TBI care and research will take a commitment of financial resources.
A process that engages a broad coalition of stakeholders in TBI care and research is critical to enabling the consideration of diverse opinions on necessary actions and metrics, and for ensuring that lessons from impactful research and from efforts that advance infrastructure and improve clinical care are discussed and disseminated.
A RESEARCH AGENDA TO ACCELERATE THE EXPANSION OF KNOWLEDGE
The following eight areas are among the most urgent priorities for continued and expanded research to address existing gaps in the evidence base for action to improve TBI prevention, care, and recovery.
- Conduct national and international epidemiological studies to better understand the scope and burden of TBI and inform prevention efforts.
Every segment of the population can experience TBI. Population-based surveillance for TBI relies largely on analysis of hospital diagnostic codes and information collected from such sources as death certificates, incidents recorded in trauma databanks, and the U.S. National Vital Statistics System. Currently available data underestimate the incidence, prevalence, and burden of TBI. In particular, there is currently no good way to estimate the many milder-spectrum injuries in which acute medical care may not have been sought or care was provided in non–trauma care settings, such as outpatient clinics or sports medicine centers. These cases represent the base of a “TBI iceberg” that cannot be identified today through any of the current TBI surveillance approaches.
- Understand the economic impact of TBI both within health care and within the family and broader community.
Health economics research is necessary to better understand the full costs of TBI, particularly the burden of indirect costs associated with longer-term symptoms, and to undertake cost/benefit analyses of TBI interventions. For example, teleconsultation may provide one potential opportunity for cost-effective follow-up with patients in resource-poor areas, but may not be feasible or effective in all circumstances or for all patients.
- Understand how combinations of injury characteristics, individual factors, and social-environmental variables affect short- and long-term care and outcomes after TBI.
Differential outcomes after TBI are associated with a broad range of factors, including preinjury status and comorbidities, as well as such personal, social, and environmental factors as age, biological sex and gender, race, ethnicity, socioeconomic status, insurance status, employment status, and geographic location. Significant gaps remain in understanding why and how these factors act and interact to affect TBI symptoms and recovery. Involving the social sciences as well as clinical and economic disciplines will be important in understanding and addressing how social determinants of health impact TBI outcomes.
- Enhance research to understand and reduce disparities in TBI incidence, diagnosis, care, and outcomes.
Information obtained from studies addressing item C above would yield important insights that could help identify approaches for overcoming inequities and disparities associated with TBI. Establishing a TBI system that can meet the needs of all patients and families will require designing, evaluating, and implementing such strategies while at the same time deimplementing practices that are that are contraindicated by the evidence or exacerbate disparities.
- Expand the number and breadth of validated tools for measuring TBI risk factors and improving diagnosis, classification, monitoring, short- to long-term outcome assessment, and prognostication.
The heterogeneous nature of TBI requires multimodal information, including clinical assessments, imaging results, and results from blood-based biomarker tests. New types of neuroimaging, biofluid-based, and physiological biomarkers are in development, and if validated, will be able to provide further information that could be collected from patients. Approaches that synthesize multimodal data and incorporate the resulting information into clinical practice guidelines and decision support tools will improve diagnosis and classification of TBI, aid in prognosis of a person’s anticipated recovery trajectory, and enable more effective monitoring of the response to care.
- Develop evidence-guided therapies for treating TBI and improving outcomes.
Despite the progress made over the past several decades in understanding the molecular and cellular mechanisms of TBI, these advances have yet to be translated to a single successful Phase 3 clinical trial or treatment for the brain in healing from TBI during acute-stage care. An array of shortcomings has contributed to this record of failure in TBI clinical trials. Novel therapies are needed, and achieving this goal will likely require a variety of efforts to improve the translation of research to practice.
- Innovate and disseminate improved designs for coordinated TBI care in organizations and regions, with special attention to patients’ and families’ long-term needs and follow-up.
Further research conducted in pragmatic environments is needed to understand how to improve outcomes of TBI in real-world settings of assessment, care, recovery, and reintegration—especially research conducted in environments other than inpatient hospital settings. In addition, pilot testing is needed to develop, evaluate, and establish strategies for better integrating the diverse components and stakeholders that make up the TBI system.
- Expand TBI research in areas with a weak history of TBI focus, including health care quality, health economics, and implementation science research.
Better understanding is needed of the scope and economic impact of TBI within health care and within families and the broader community. Existing data sources for population-based surveillance have limitations, and there are challenges in calculating the full costs associated with TBI. Those who study health care quality can help the TBI field study,
identify, and develop new knowledge of ways to make care safer, more effective, more timely, more efficient, more patient- and family-centered, and more equitable. The field of implementation science, including planning for implementation in study designs, can support the effective translation of new knowledge into practice, as well as deimplementation of ineffective or contraindicated practices. Further engaging and collaborating with those from such key fields would broaden the scope of expertise brought to bear on addressing the challenges of TBI.
REFERENCES
Berwick, D. M. 2009. What “patient-centered” should mean: Confessions of an extremist. Health Affairs 28(4):w555-w565.
IOM (Institute of Medicine). 2007. The learning healthcare system: Workshop summary. Washington, DC: The National Academies Press.
NASEM (National Academies of Sciences, Engineering, and Medicine). 2016. A national trauma care system: Integrating military and civilian trauma systems to achieve zero preventable deaths after injury. Washington, DC: The National Academies Press.
This page intentionally left blank.
